EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10032/2020 Rev. 3  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for fluxapyroxad, 
hymexazol, metamitron, penflufen and spirotetramat in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as  regards maximum residue levels for fluxapyroxad, 
hymexazol, metamitron, penflufen and spirotetramat in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the 
Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article 14(1)(a)  and Article 49(2) thereof,  
Whereas:  
(1) For fluxapyroxad , hymexazol, metamitron and spirotetramat  maximum residue levels 
(MRLs) were set in  Part A of  Annex III to Regulation (EC) No 396/2005. For 
penflufen no MRLs were  set in Regulation (EC) No  396/2005, and as th is active 
substance  is not included in Annex  IV to that Reg ulation, the default value of 
0.01 mg/kg laid down in Article  18(1)(b) of Regulation (EC) No  396/2005  applies . 
(2) For fluxapyroxad  the European Food Safet y Authority ( ‘the Authority ’), submitted a 
reasoned opinion on the review of the existing MRLs in accordance with Article  12(1) 
of Regulation (EC) No  396/20052. For some products, it recommended raising or 
keeping the existing MRLs. The MRLs for those products should be set in Annex  II to 
Regulation (EC) No  396/2005 at the level identified by the Authority . The Authority 
concluded that concerning the MRL s for apricots, root and tuber vegetables, brassica 
vegetables, leaf vegetables, herbs and edible flo wers, cardoons, celeries, Florence 
fennels, globe artichokes, leeks, rhubarbs, pulses, cereals, herbal infusions from leaves 
and herbs , herbal infusions from roots and sugar  plants  some information was not 
available and that further consideration by risk m anagers was required . As there is no 
risk for consumers, the MRLs for those products  should be set in Annex  II to 
Regulation (EC) No  396/2005 at the level identified by the Authority. All of these  
MRLs will be reviewed; the review will take into account th e information available 
within two years from the publication of this Regulation.  
(3) For hymexazol  the Authority submitted a reasoned opinion on the  review of the  
existing MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20053. It 
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for fluxapyroxad  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2020 ;18(1):5984 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for hymexazol  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(1 1):5895 .  
EN 2  EN recommended l ower ing the MRL for sugar beet root s. As there is no risk for 
consumers, this MRL should be set in Annex  II to Regulation (EC) No  396/2005 at the  
level identified by the Authority.  
(4) For metamitron  the Authority  submitted a reasoned opinion on the review of the 
existing MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20054. It 
recommended lower ing the existing MRLs for apples, pears, beetroot s, carrots, 
horseradishes, parsnips, parsley roots/Hambu rg roots parsley, turnips , onions  and 
sugar beet roots . The MRLs for those products should be set in Annex  II to Regulation 
(EC) No  396/2005 at the level identified by the Authority . The Authority concluded 
that concerning the MRL s for strawberries, Roman rocket/rucola , baby leaf crops 
(including brassica species) , spinaches and similar leaves , herbal infusions from leaves 
and herbs, herbal infusions from roots, seed spices and fruit spices some information 
was not available and that further consideration b y risk managers was required . As 
there is no risk for consumers, the MRLs for those products also should be set in 
Annex  II to Regulation (EC) No  396/2005 at the level identified by the Authority. All 
of these MRLs will be reviewed; the review will take in to account the information 
available within two years from the publication of this Regulation.  
(5) For penflufen  the Authority submitted a reasoned opinion on the  review of the  existing 
MRLs in accordance with Article  12(1) of Regulation (EC) No  396/20055. It 
recommended keeping the existing MRL for potatoes . This MRL should be set in 
Annex  II to Regulation (EC) No  396/2005 at the level identified by the Authority . 
(6) For spirotetramat  the Authority submitted a reasoned opinion on the review of the 
existing MRL s in accordance with Article  12(1) of Regulation (EC) No  396/20056. It 
proposed to change the residue definition.  It recommended lower ing the existing 
MRLs for citrus fruits, pome fruits, strawberries, table olives, kiwi, avocados, bananas, 
granate apples/ pomegranates , pineapple s, other root and tuber vegetables except sugar 
beets, garlic, shallots, Solanaceae and Malvaceae , witloofs/Belgian endives , olives for 
oil production and chicory roots . For other products, it  recommended raising or 
keeping the existing MRLs. The MRLs for those products should be set in Annex  II to 
Regulation (EC) No  396/2005 at the level identified by the Authority . The Authority 
concluded that concerning the MRL s for Brussels sprouts and kohlrabies  some 
information was not available and that further consideration by risk managers was 
required . As there is no risk for consumers, the MRLs for those products should  also 
be set in Annex  II to Regulation (EC) No  396/2005 at the level identified by the 
Authority . All of t hese MRLs will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation.  
(7) Existing Codex maximum residue limits (CXLs)  were taken into account in the 
reasoned opinions of the  Authority. CXLs , which are safe for consumers in the Union 
were considered for MRL setting.  
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for metamitron  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2020;18(1):5959 . 
5 European Food Safety Authority; Reasoned opinion on  the review of the existing maximum residue 
levels for penflufen  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(10):5840 . 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for spirotetramat  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2020;18(1):5960 .  
EN 3  EN (8) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or CXLs exist, MRLs should be set at 
the specific limit of determination  (LOD)  or the default MRL should apply, as 
provided for in Article 18(1)(b) of Regulation (EC) No  396/2005.  
(9) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . As regards several substances, 
those laboratories concluded that for certain commodities technical development 
requires  the setting of specific LODs . 
(10) In the context of a procedure for the authorisation of the use of a plant protection 
product containing the active substance spirotetramat on “other small fruits and 
berries”, an application was submitted in accordance with A rticle  6(1) of Regulation 
(EC) No  396/2005 for modification of the existing MRLs. In accordance with 
Article  8 of Regulation (EC) No  396/2005, this application was evaluated by Germany 
and the evaluation report was forwarded to the Commission. The Authorit y assessed 
the evaluation report and gave a reasoned opinion7 on the proposed MRLs. It 
recommended raising the existing MRLs  for those products. The MRLs for those 
products should be set in Annex  II to Regulation (EC) No  396/2005 at the level 
identified by  the Authority . 
(11) In accordance with Article  6(2) and (4) of Regulation (EC) No  396/2005 applications 
for import tolerances were submitted for fluxapyroxad used in the United States on 
“other root and tuber vegetables except sugar beets” and Brazil on coffee  beans. The 
applicants claim that the authorised uses of that substance on such crops in those 
countries lead to residues exceeding the MRL contained in Regulation (EC) No 
396/2005 and that a higher MRL is necessary to avoid trade barriers for the 
importat ion of those crops. In accordance with Article  8 of Regulation (EC) 
No 396/2005, th ose application s were  evaluated by the Member States concerned  and 
the evaluation report s were  forwarded to the Commission.  The Authority assessed the 
applications and the e valuation reports, examining in particular the risks to the 
consumer and, where relevant, to animals and gave reasoned opinions on the proposed 
MRLs8. It forwarded those opinions to the applicants, the Commission and the 
Member States and made them availab le to the public.  
(12) As regards all applications, t he Authority concluded that all requirements with respect 
to data were met and that the modifications to the MRLs requested by the applicants 
were acceptable with regard to consumer safety on the basis of a consumer exposure 
assessment for 27  specific European consumer groups. It took into account the most 
recent information on the toxicological properties of the substances. Neither the 
lifetime exposure to these substances via consumption of all food product s that may 
contain them, nor the short -term exposure due to high consumption of the relevant 
products showed that there is a risk that the acceptable daily intake or the acute 
reference dose is exceeded.  
(13) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to the MRLs 
fulfil the requirements of Article  14(2) of Regulation (EC) No  396/2005.  
                                                 
7 Reasoned opinion on the m odification of the existing maximum residue levels for spirotetramat in small 
fruits and berries . EFSA Journal 2019;17(11):5904 . 
8 Reasoned opinion on the  setting of import tolerances for fluxapyroxad in certain root crops and coffee 
beans . EFSA Journal 2020;18(1):5950 .  
EN 4  EN (14) Through the World Trade Organisation, the trading partners of the  Union were 
consulted on the new MRLs and their comments have been taken into account.  
(15) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(16) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional arrangement for products which have 
been produced before the modification of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(17) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(18) The measures provided for in th is Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed . 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II  and III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the Union or imported into the Union 
before [ Office of Publication: please insert date 6 months after entry into force ]. 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European U nion.  
It shall apply from [Office of Publication: please insert date 6 months after entry into force] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN